Ultrasound-guided Pulsed Radiofrequency for Plantar Fasciitis

NCT ID: NCT02242513

Last Updated: 2016-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-07-31

Brief Summary

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Although there are many conservative method for plantar fasciitis, patients might spend 2 years to achieve resolution. Recent study have shown that pulsed radiofrequency (PRF) lesioning of peripheral nerve can alleviate kinds of pain condition. However there are no studies of PRF lesioning of the tibial nerve in patients with plantar fascilitis by using ultrasound-guided (UG) techniques.

Detailed Description

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Patients with unilateral plantar Fasciitis will be enrolled and randomized into intervention and control group. One dose of sono-guided PRF is applied in the intervention group and xylocaine in control group. Outcome measurements included visual analog scale (VAS)、foot health status questionnaire and the thickness of plantar fascile measured by musculoskeletal ultrasonography at different follow-up frame (4th week, 2nd month, 3rd month after treatment).

Conditions

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Plantar Fasciitis

Keywords

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Pulsed mode radiofrequency Plantar Fasciitis Ultrasound-guided

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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pulsed mode radiofrequency

Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade, was found to be able to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue in the absence of neural injury. One dose of PRF was given in tibial nerve behine the medial ankle in intervention group.

Group Type ACTIVE_COMPARATOR

Pulsed radiofrequency (PRF)

Intervention Type DEVICE

Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade, was found to be able to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue in the absence of neural injury.

Xylocaine

2 c.c xylocaine was given in tibial nerve behind the medial ankle in control group.

Group Type PLACEBO_COMPARATOR

Xylocaine

Intervention Type DRUG

Interventions

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Pulsed radiofrequency (PRF)

Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade, was found to be able to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue in the absence of neural injury.

Intervention Type DEVICE

Xylocaine

Intervention Type DRUG

Other Intervention Names

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Neurotherm NT1000, Neurotherm Inc., USA

Eligibility Criteria

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Inclusion Criteria

* Heel pain more than 3 months
* Age more than 20 year-old
* The increased thickness of plantar fascile (\>4mm) measured by sonography
* Must be conscious
* Not receive steroid or other injection in plantar fascile in past 6 months

Exclusion Criteria

* Cancer of any site
* Coagulopathy
* Pregnancy
* Inflammation status
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yung-Tsan Wu

OTHER

Sponsor Role lead

Responsible Party

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Yung-Tsan Wu

Attending Physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Liang-Cheng Chen, MD, MS

Role: STUDY_DIRECTOR

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center,

Locations

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Tri-Service General Hospital, School of Medicine, National Defense Medical Center

Taipei, Neihu District, Taiwan

Site Status

Countries

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Taiwan

References

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Martin DC, Willis ML, Mullinax LA, Clarke NL, Homburger JA, Berger IH. Pulsed radiofrequency application in the treatment of chronic pain. Pain Pract. 2007 Mar;7(1):31-5. doi: 10.1111/j.1533-2500.2007.00107.x.

Reference Type BACKGROUND
PMID: 17305676 (View on PubMed)

Van Zundert J, Patijn J, Kessels A, Lame I, van Suijlekom H, van Kleef M. Pulsed radiofrequency adjacent to the cervical dorsal root ganglion in chronic cervical radicular pain: a double blind sham controlled randomized clinical trial. Pain. 2007 Jan;127(1-2):173-82. doi: 10.1016/j.pain.2006.09.002. Epub 2006 Oct 18.

Reference Type BACKGROUND
PMID: 17055165 (View on PubMed)

Rohof OJ. Radiofrequency treatment of peripheral nerves. Pain Pract. 2002 Sep;2(3):257-60. doi: 10.1046/j.1533-2500.2002.02033.x.

Reference Type BACKGROUND
PMID: 17147740 (View on PubMed)

Thapa D, Ahuja V. Combination of diagnostic medial calcaneal nerve block followed by pulsed radiofrequency for plantar fascitis pain: A new modality. Indian J Anaesth. 2014 Mar;58(2):183-5. doi: 10.4103/0019-5049.130824.

Reference Type RESULT
PMID: 24963184 (View on PubMed)

Erken HY, Ayanoglu S, Akmaz I, Erler K, Kiral A. Prospective study of percutaneous radiofrequency nerve ablation for chronic plantar fasciitis. Foot Ankle Int. 2014 Feb;35(2):95-103. doi: 10.1177/1071100713509803. Epub 2013 Oct 28.

Reference Type RESULT
PMID: 24165571 (View on PubMed)

Sean NY, Singh I, Wai CK. Radiofrequency microtenotomy for the treatment of plantar fasciitis shows good early results. Foot Ankle Surg. 2010 Dec;16(4):174-7. doi: 10.1016/j.fas.2009.10.008. Epub 2009 Nov 25.

Reference Type RESULT
PMID: 21047605 (View on PubMed)

Other Identifiers

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TSGH-C103-115

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TSGHIRB-2-102-05-95

Identifier Type: -

Identifier Source: org_study_id